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Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders (DBE)

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ClinicalTrials.gov Identifier: NCT01184690
Recruitment Status : Unknown
Verified August 2010 by Shanghai Changzheng Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : August 19, 2010
Last Update Posted : August 19, 2010
Sponsor:
Information provided by:
Shanghai Changzheng Hospital

Tracking Information
First Submitted Date  ICMJE August 16, 2010
First Posted Date  ICMJE August 19, 2010
Last Update Posted Date August 19, 2010
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • completion whether the complete enteroscopy is achieved? [ Time Frame: 2 hours ]
    The completion rate for examination of the entire small intestine
  • lesion-discovery [ Time Frame: 2 hours ]
    lesion-discovery rate
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • observation time [ Time Frame: 2 hours ]
  • Number of Participants with Adverse Events [ Time Frame: 2 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
Official Title  ICMJE Prospective Trial Comparing Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
Brief Summary Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout the entire small intestine. Although the originally described method requires two operators, the investigators have recently developed a method to perform DBE by a single operator. The investigators here assessed the clinical usefulness of this one-person method in comparison to the conventional two-person DBE.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Small-Bowel Disorders
Intervention  ICMJE
  • Procedure: Single-operator double-balloon endoscopy
    Single-operator double-balloon endoscopy
  • Procedure: dual-operator double-balloon endoscopy
    dual-operator double-balloon endoscopy
Study Arms  ICMJE
  • Active Comparator: Single-operator DBE
    Single-operator double-balloon endoscopy
    Intervention: Procedure: Single-operator double-balloon endoscopy
  • Active Comparator: Dual-operator DBE
    Dual-operator double-balloon endoscopy
    Intervention: Procedure: dual-operator double-balloon endoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 18, 2010)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2011
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. suspected or known small-bowel disease
  2. age: 16-70

Exclusion Criteria:

  1. pregnancy
  2. coagulation disorders
  3. prior surgery of the small bowel and colon
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01184690
Other Study ID Numbers  ICMJE DBE-S vs D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jian Shi, Shanghai Changzheng Hospital
Study Sponsor  ICMJE Shanghai Changzheng Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jian Shi, MD Shanghai Changzheng Hospital
Principal Investigator: Bin Shi, MD Shanghai Changzheng Hospital
Study Director: Wei-Fen Xie, MD Shanghai Changzheng Hospital
PRS Account Shanghai Changzheng Hospital
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP